Novel Non-Invasive Monitoring Parameter in a Hospital Setting
A Novel Cardio-Respiratory Parameter in a Hospital Setting
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Colorado
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Denver、Colorado、美国、80262
- The University of Colorado Health Sciences Center (UCHSC)
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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University Medical Center (OSUMC)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subjects 18 years old or older
- Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
- Subjects on general care floor
Exclusion Criteria:
- Severe contact allergies to standard adhesive materials
- Abnormalities that may prevent proper application of the device
- Women who are pregnant or lactating
- Subjects with significant arrhythmia
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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In-patient Volunteers
In-patients from the hospital who choose to participate in the study
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
大体时间：Participants were monitored for average of 30 minutes
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Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms.
Each patient served as its own control.
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Participants were monitored for average of 30 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
大体时间：Participants were monitored on average for 30 minutes
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The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject. The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software |
Participants were monitored on average for 30 minutes
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合作者和调查者
调查人员
- 首席研究员：Sergio Bergese, MD、The Ohio State Medical Center, Dept of Anesthesia
- 首席研究员：Robert McIntyre, MD、University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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